Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial
This prospective study was designed to compare the quality of life after sphincter saving
surgery and abdominoperineal resection. Because of ethical issues, it is difficult to
conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal
function, patient will be attributed to two different operative method groups. Sample sized
was calculated as 294 patients in the estimated enrollment of 1 to 3(APR: ISR)
- Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid
- Patient who understands and accepts to sign the informed consent form
- Confirmed preoperative colonoscopic biopsy (adenocarcinoma)
- Proper bone marrow function
- Proper renal function
- Proper liver function
- No severe comorbidity
- Metastatic lesion detected in preoperative assessment
- Previous history of cancer disease. (except patients with skin cancer)
- Severe heart disease, congestive heart disease.
- Severe lung disease, respiratory failure.
- Mental illness.
- Invasion to prostate, bladder and combined resection needed (partial or radical.•
Legally prohibited for clinical trial.
- Pregnancy or breast feeding.
- Previous disease or disability expected to influence the assessment of postoperative
quality of life.
Type of Study:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Quality of life
Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).
Outcome Time Frame:
Sung-Bum Kang, Ph. D.
Seoul National University Bundang Hospital
Korea: Food and Drug Administration
- Rectal Cancer
- Low Rectal Cancer
- Sphincter preservation
- Abdominoperineal resection
- Quality of life
- Sexual function
- Urinary function
- Oncologic outcome
- Rectal Neoplasms